Blood products for transfusion in Japan are regulated by the pharmaceutical affairs law enacted by the Ministry of Health and Welfare. The quality system of GMP regulation for pharmaceutical products was introduced in 1976 and was applied for blood centers and blood products. GMP consists of the regulation for facilities and equipment (GMP hard), and quality management (GMP soft). The aims of GMP are prevention of human errors, prevention of contamination and quality defect of drugs, and constitution of quality system for manufacturing high quality pharmaceutical products. GMP contains GMP system, standard documents, management of manufacture, quality control, calibration, validation, management for complaints and recall, internal audit, and educational training. Blood centers in Japan have just started to use GMP and they look to be behind to other pharmaceutical companies particularly in the respect of GMP Soft. Therefore, we have to promote activities for carrying out GMP especially in quality management.
